Session 2
An unexpected Request for Additional Information (RFAI) letter from FDA threatens to derail your company’s approval timeline and impact this year’s earnings. What should you do now in this high-pressure situation? In this interactive session, you will collaborate in breakout groups to explore how to communicate the situation’s implications to different stakeholders including senior management, key opinion leaders, and your regulatory staff.
After completing this workshop, you will be able to:
Develop clear, concise communication strategies for crisis situations.
Predict how various department heads will react to regulatory challenges.
Craft presentations that preemptively address stakeholders' concerns.
Secure agreement on alternative solutions that align with organizational goals.
Discuss methods for communicating critical information to regulatory staff in a manner that maintains a department’s positive culture.
Analyze benefits vs. risks for different courses of action.